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South San Francisco, CA

Senior Quality Engineer, Reagents

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Position description

The Quality Engineer is an enthusiastic, self motivated person with great communication skills who can support our quality management and regulatory systems development. The Quality Engineer will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. The candidate will be comfortable in a rapidly evolving Biotech start-up environment assisting in the implementation of a value-added QMS based on CLIA, CAP, CLEP, ISO 13485:2003 and FDA QSR regulations. 

What you'll do

  • Reduce process variation and increase process rigor throughout operations (focusing on reagent and DNA library manufacturing) using quality tools, techniques and statistics
  • Create, update, review and develop Quality Management System standard operating procedures and supporting work instructions based in CLIA, CAP, CLEP, ISO 13485:2016 and FDA Quality System Regulations
  • Support training of personnel in requirements of quality tools and techniques, QMS based on CLIA, CAP, CLEP, ISO 13485:2016/FDA 21 CFR 820 requirements
  • Perform root cause data analysis, using statistical techniques and maintain supporting databases for CAPA systems
  • Write and perform qualification, verification/validation protocols (e.g. IQ/OQ/PQ)
  • Create and maintain quality metrics as they relate to manufacturing processes and related activities for analysis and continual improvement
  • Support supplier qualification and evaluation
  • Support Material Review Board (MRB) activities
  • Support Change Control Board quality system/validation representation
  • Support Product Life Cycle/Development (PLC/NPD) quality/regulatory inputs for design and phase reviews
  • Any and all other undefined tasks, as directed by your supervisor

About you

  • B.S./B.A. in Engineering, Chemistry or Life Science. 5+ years as a QE or equivalent with experience in medical device environment with knowledge of database management, CLIA, CAP, CLEP, ISO 13485:2003/FDA QSR quality systems lead auditor training, CAPA system maintenance, and process development, verification/ validation
  • Critical to have a working knowledge of Quality Statistics, tools, SPC, Six Sigma and Lean techniques and methodologies
  • Ability to apply quality tools to develop new quality processes focused on process rigor and reduction in variation throughout operations
  • Experience in the development and maintenance of databases for tracking of quality system data and production defects
  • Active participation in root cause analysis and process improvement using quality methodologies, DMAIC, SPIOC, etc.
  • Basic understanding of Chemistry and Molecular Biology, as it pertains to DNA sequencing
  • Experience with developing and improving processes within a reagent manufacturing environment
  • Experience in medical device / Biotech start-up / fast growth company, or similar working environment
  • Working knowledge of cGMP’s
  • ISO15189 Experience a plus
  • Advanced education a plus
  • ASQ CQE highly preferred 

About Counsyl

Counsyl is a health technology company that offers DNA screening for diseases that can impact men, women and their children. The Counsyl philosophy is simple: screen for diseases where advanced knowledge makes a difference in health outcomes, whether it’s changing a behavior, pursuing preventative measures, or simply preparing for what lies ahead.

The Counsyl team includes an accomplished group of problem-solvers — top engineers, scientists, and designers — who are taking the lead on building the modern clinical laboratory. Scientific rigor, custom robotics, and software are at the heart of every Counsyl product, resulting in better, faster and more affordable screens that are broadly accessible. Beyond the laboratory, Counsyl offers doctors and patients a technology platform for results delivery in real time, with on-demand access to board-certified genetic counselors.

Counsyl has screened more than 700,000 patients and served more than 6,000 health care professionals in its CLIA-certified, CAP-accredited and NYS CLEP-permitted clinical laboratory. The company has raised a total of $102 million and is privately backed by Pilot Growth Equity, Goldman Sachs Asset Management, Founders Fund, Felicis Ventures, David Drummond, and other high profile investors.

Interview process

Counsyl is driven by some of the brightest people in the industry. Our interview process is geared to ensure that we continue to hire the very best.

Our interview process is composed of practical and situational interviews in a series of settings spanning Skype, practical exams, and in-person meetings. Our goal is to gauge both your ability to succeed in the first 90 days as well as your capacity to scale with us as we grow.

Why Counsyl?

Throughout it all, we are looking to understand why you are driven to be a part of our company. Specifically, we want to know how you identify with our mission and will contribute to our team.

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